Needleless jet injection device comprising a moulded-on cartridge

ABSTRACT

A needleless jet injection device including a barrel fitted with a cap at one of the ends thereof. Relative motion of the cap component actuates a setting device operably connected to a precussive member. A cartridge arranged at the other end of the barrel comprises two elements, i.e., a first element forming a container for the active principle, and a second element consisting of a plastic shell enclosing the first element.

FIELD OF THE INVENTION

The present invention relates to a device permitting the injection of aproduct, in particular a pharmaceutical product, into the human oranimal body.

It concerns more particularly an apparatus without hypodermic needle,equipped with an arming system, which permits the subcutaneous,intradermal or intramuscular administration of medical substances orvaccines, contained in a single dose, and forming a cartridge.

BRIEF DESCRIPTION OF THE PRIOR ART

Apparatuses for injection by transcutaneous jet without needle are knownwhich have been developed for veterinary or human medicine. The absenceof a needle simplifies the use of the apparatus and does not requirespecific knowledge on the part of the user. They are generally used formass vaccination campaigns and are designed to be used quickly bynonspecialist personnel. The use of a jet avoids to the greatest extentbacterial and/or viral contamination of one subject by another, whichhappens in those cases where the same needle is used by several subjectswithout being sterilized. These apparatuses are generally designed in apistol shape, equipped with a receptacle for the product which is to beinjected, driven through a nozzle, by the action of a plunger displacedwithin a chamber, filled beforehand with the substance, the plungerbeing moved by a striker. Alternatively the pistol includes a breech ora magazine containing a cartridge, also placed in the axis of thestriker.

Thus, the document WO 95/03844 discloses a device for injection by jetwithout needle, which is provided with an arming device activated by therotation of a cap situated at one of the ends of the body of the device.

The document WO 95/27523 describes a device for injection by jet withoutneedle, provided at one of its ends with a cartridge formed in onepiece.

The document WO 96/15821 describes a cartridge including a capsule onwhich a sleeve tube is fitted by force and induces stresses on thecapsule.

Finally, the document EP 427 457 describes a device for injection by jetwithout needle, provided with a cartridge which cooperates at one of theends of the device, by way of a component forming a breech.

Given the mode of action of the striker, which has a substantial kineticenergy before reaching the plunger of the cartridge, which can, in caseswhere the cartridge is not correctly arranged in the magazine of thepistol, cause it to burst at the start of the injection, theseapparatuses are not reliable and are not easy to use if their use isinfrequent.

The present invention is therefore aimed at overcoming thesedisadvantages by making available a device which is without magazine fora cartridge and which permits the injection by jet, without needle, ofthe product contained in a cartridge placed directly at the head of thedevice, under strictly aseptic conditions, for a single use.

For this purpose, the cartridge for injection of a product, inparticular a pharmaceutical product, by jet without needle, for singleuse, and intended to be fixed at a first end of the body of an injectiondevice, the second end of the body receiving a cap which is able, byvirtue of a relative movement of the body, to drive an arming device,cooperating with a percussion member intended to cooperate with thecartridge, is characterized in that it includes two elements:

the first element made of glass forms the receptacle intended to containthe product;

the second element consists of an envelope of plastic material which isovermoulded on the first element.

Other characteristics and advantages of the present invention will beevident from the description which follows, with reference being made tothe attached drawings which show an illustrative embodiment of theinvention, without this embodiment in any way being of a limitingcharacter. In the figures:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view, in front elevation and in section, of the deviceaccording to the invention, in the armed position;

FIG. 2 is a plan view, in front elevation and in section, of the deviceaccording to the invention, in the triggered position;

FIG. 3 is a view, on a larger scale and in section, of a cartridgecontaining a dose of injectable product;

FIG. 4 is a view illustrating another method of fixing the cartridge onthe device;

FIG. 5 is a sectional view illustrating the movement of the striker onthe elastomeric stopper contained in the cartridge;

FIG. 6 is a perspective view of the clamp system intended to hold therod of the striker;

FIG. 7 is a plan view, in front elevation and in section, of the deviceaccording to another embodiment of the invention, including a releasableconnection member;

FIG. 8 is a perspective view of the releasable connection member;

FIG. 9 is a plan view, in front elevation and in section, of the deviceaccording to the invention;

FIG. 10 is a plan view, in front elevation and in section, of acartridge according to a second embodiment;

FIG. 11 is a plan view, in side elevation and in section, of a cartridgeaccording to a second embodiment.

DETAILED DESCRIPTION

According to a preferred embodiment, the device which is the subject ofthe invention essentially comprises a body 1 extending in the form of atube, in particular of straight cylindrical cross-section, intended toreceive an arming device 2 connected to a cap 3, in particular knurledin order to improve its grip by the user, provided at one of the ends 4,5 of the body. Viewing FIG. 8, the cap is made from a tube portion, ofsimilar cross-section to that of the main body of the said device, thediameter of which, however, is greater in order to permit a relativerotational movement thereof about the body, and it cooperates by way ofa catch device 6, in particular of the key type, with a ring 7, itselfintegral with a clamp 8. The ring is engaged with play at the end of thebody 1 and can turn freely in the body, its axial position in the tubebeing determined by a radial abutment 9 on the wall of the tube andfitting in a circular groove 10 formed on the said ring 7 and positionedopposite the abutment 9. The rotational movement from the cap 3 istransmitted to the ring by way of the catch device 6. The ring 7 isadditionally provided with a central recess 11 for the passage of astriker 12, free in axial translation and leading inside the clamp 8.This clamp constitutes one of the links of the arming device. Of overallcylindrical shape, it is equipped with a plurality of cutouts 13oriented substantially parallel to the axis of the body in such a way asto form a plurality of flexible tabs 14 (FIG. 6). In addition, the innerbore 15 (FIG. 8) of the clamp 8 is tapped in such a way as to formimpressions which can be screwed around a threaded portion 16 providedon a rod 17 of the percussion striker 12. The thread pitch is determinedas a function of the chosen demultiplication and the stiffness constantof a spring 18. The power of the striker can also be adjusted by meansof pre-setting the compression of the spring, it being possible for thespace between the turns to be set by way of a knurled wheel 46 (as shownin FIG. 1) displaced on the rod 17 and in contact with 18 oralternatively by way of a stack of washers arranged between the spring18 and a ring 25 as shown in FIG. 2. The turns of the spring 18 arecompressed by the relative rotational movement between the cap 3 and thebody 1.

According to an advantageous characteristic of the invention, the cap 3includes a safety device 47 (FIG. 9) which covers the rod of the striker12. This safety device 47 is connected to the cap 3 by way of a hinge 48which permits a rotational movement of the safety device 47, between ahorizontal locked position shown in dotted lines and an unlockedvertical position shown in solid lines of the rod of the striker 12. Therotation of the safety device 47 to the horizontal position also makesit possible to act on the catch member 6 between the cap 3 and the ring7. This is because it is essential that the user can arm the percussiondevice (striker 12 and rod 17) only when the safety device 47 iscovering the rod of the striker 12 (horizontal position); this is why,when the safety device 47 is locked (horizontal position) on the cap 3,it acts on the catch member 6 in such a way that the latter permits thetransmission of the rotational movement between the cap 3 and the ring7. In greater detail, the hinge 48 of the safety device 47 is pivoted inan offset manner so as to create a camming surface against catch member6 which is basically a detent member. Once the safety device 47 has beenrotated to the armed position (indicated in phantom lines), hinge 48cams the catch member 6 into the corresponding detent recess formed inring 7, the catch member 6 effectively connecting the cap 3 and the ring7 so as to allow mutual rotation and subsequent triggering.

When the safety device 47 is unlocked (vertical position), that is tosay when it is no longer covering the rod of the striker 12, it nolonger acts on the catch member 6 and the user cannot arm the percussiondevice.

There is therefore a rod 17, forming a plunger, arranged inside the saidbody 1, its length being chosen in such a way that its end 19, notconnected to the clamp 8, extends toward the end 5 of the body 1 whenthe arming device 2 is operational. The lower end of rod 17 is guided byannular guide 17a.

The peripheral envelope 20 of the clamp is held by a spacer sleeve 21,also of a cross-section similar to that of the body, the externaldiameter of which corresponds to the internal diameter of the body insuch a way as to form guide zones. Its axial position inside the bodybeing limited, on the one hand, at one of its ends 23, 24, by a pin 22passing radially right through the striker 12, and, on the other hand,its other front end constituting a bearing surface for a spring 43; theaxial position of the spring and its other bearing surface beingadditionally limited, for example, by a ring 25 inserted in the body,integral with the rod 17 and axially immobilized, if appropriate, by aclip ring 26, or by a shoulder formed on the rod.

In the arming position, the user imparts a relative rotational movementbetween the body 1 and the cap 3; as we have seen above, the rotationalmovement of the cap is transmitted both to the said ring 7 and to theclamp 8 integral with the latter; the several threads of the clamp 8 inengagement with those of the rod make it possible to initiate themovement of translation between the rod 17 (forming the screw) and theclamp 8 (forming the nut) and the relative closing-together of these twocomponents. This translation movement compresses the turns of the spring18 until the space between the turns is reduced to the maximum.According to another embodiment, the spiral spring can be replaced by ahelical spring or by any other elastic device.

In the disarm or trigger position, the user exerts a slight push on thestriker 12, the pin 22, projecting radially and in contact with one ofthe front faces 23, 24 of the spacer sleeve, transmits a relativemovement (through slot 8a, FIG. 8) of translation between the spacersleeve 21 and the clamp 8, which releases the end thereof from a conicalbearing surface 27 provided at the bottom of the bore of the spacersleeve 21. The thrust of the spring 18 combined with the flexibility ofthe tabs of the clamp frees the respective threads previously inengagement, thereby provoking an almost impulse movement of translationof the whole rod.

According to another embodiment of the invention (FIGS. 7 and 8), thereis arranged, between the cap 3 and the arming member integral with theclamp 8 contained in the body 1, a connection member 38 which permitsthe relative rotational movement between these two components only inone direction of rotation. The reason is that, to avoid any damage tothe apparatus and to simplify its handling by the user, a releasableconnection member 38 is provided which is composed principally of twocomponents 39, 40, in particular of circular cross-section. One of thecomponents 39 is integral with the cap 3, while the other 40 isconnected to the clamp 8 and to the body 1 by way of a groove 44, andeach of the components also has, at their contact face, a plurality ofraised zones (ratchet connection) 41. These zones 41 have a profilewhich is able, on the one hand, to permit a relative sliding between thecomponents 39 and 40 in one direction of rotation between the cap 3 andthe body 1 and, on the other hand, to transmit the moment in the otherdirection of rotation of the cap 3 relative to the body 1.

The raised zones 41 are preferably formed from a plurality of teeth, inparticular of triangular cross-section.

For the connection member 38 to function, however, it is best not tosuppress completely the movements of the components 39 and 40 inrelation to the cap 3 and to the clamp 8; thus, when the connectionmember is active (released), it is necessary for the components 39, 40to escape longitudinally from one another and for these components toreturn to their engaged position after suppression of the moment; forthis reason, an elastic member 41a, in particular of the spring type, isarranged in line with the outer surface of one of the components 39 or40, in the area of a guide portion 42, which compensates for thetranslation movements between the components.

According to another characteristic of the invention (FIGS. 9, 11), acartridge 28 is arranged at the other end 5 of the body 1 of the device,by known means such as, in particular, being screwed on, clipped on(bushing, bayonet).

According to an advantageous characteristic of the invention, thecartridge 28 includes two elements 49, 50:

the first element 49 forms the receptacle intended to contain the activeprinciple, and it is obtained in particular from a type I medical-gradeglass, since the receptacle is to contain injectable products;

the second element 50 consists of an envelope of plastic material whichcovers the said first element 49.

The plastic material used in the overmoulding, that is to say covering,operation must be able to withstand a sterilization operation at hightemperature (in the region of 120° C.), must be approved forpharmaceutical applications, must be insensitive to the temperaturedeviations in terms of its expansion, given that the cartridges 28 aregenerally stored in an atmosphere where the temperature is between 2 and10° C. Moreover, after overmoulding on the first element 49, the plasticmaterial employed is translucent, even transparent, and can be tinted.The product called ₋₋ TPX₋₋ (polymethylpentene) will be chosen, forexample, as the plastic material.

The first element 49 made of glass, and overall of substantiallycylindrical shape, includes, at each end, an orifice 29, 30. One 30 ofthe orifices has a diameter substantially equivalent to the diameter ofthe rod 17, while the other 29, of small diameter, in particular of theorder of a few tenths of a millimeter, serves as nozzle. The internalcavity of the said cartridge is filled under vacuum with an activeprinciple 31 and is, if appropriate, covered with a film 32 of materialcompatible with the physicochemical properties of the said product, inorder to limit to the maximum the phenomenon of adsorption.

The cartridge 28, thus formed by the overmoulding of a plastic materialon a first element 49 made of glass, includes, at one of its ends, means51 (FIG. 10) permitting the engagement and fixing of the cartridge onthe nose of the injection device.

The means 51 permitting the engagement and fixing are advantageouslyformed during the overmoulding operation by way of a plurality of studs52 which project radially and are arranged along the diameter of thecartridge 28, these studs cooperating with the bayonets provided at theend 53 of the injection device.

The other end 54 of the cartridge 28 is designed as a plane surfaceintended to be applied against the surface of the skin of the user.

The outlet orifice 29 formed on this end 54 must be protected frompossible contamination by the surrounding environment, and for thispurpose there is an end cap 55 which is provided at its center with anelastomeric seal 56, in particular of silicone.

According to another embodiment, a film covering the surface of thecartridge 28 is arranged on the end 54.

This cap 55 is obtained by a process of moulding of plastic material, ifappropriate, similar to that forming the cartridge.

The end cap 55 advantageously has lateral walls 57 which enclose the endof the cartridge 28, the said walls 57 being provided, at their ends,with raised zones 58 allowing them to be clipped into impressions 59provided on the outer lateral walls of the cartridge 28, thus ensuringthat the end cap 55 is held on the cartridge.

The upper wall 60 of the end cap 55 forms a grip zone which allows theuser to position the studs 52 of the cartridge 28 in line with thebayonets of the injection device and, by a simple movement of rotation,to block the studs 52 in the bayonets and, after blocking the studs 52,when the user continues to impart this rotational movement to the endcap 55 and thus to the cartridge 28 which is integral with it, to detachthe lateral walls 57 of the end cap 55 from the impressions 59 in thecartridge 28, in such a way as to make the injection device ready foruse.

According to a first alternative, the elastomeric seal 56 is obtainedduring a simultaenous operation of moulding of the end cap 55.

According to a second alternative, the elastomeric seal 56 is attachedand fitted by force into a recess 61 provided on the internal wall 62 ofthe end cap 55.

According to another advantageous characteristic of the invention, it isintended to form a plurality of plastic material gaps in the thicknessof the plastic overmould of the cartridge 28, in order to produce slots63 for improving the visibility of the first element 49 made of glass.The cartridge 28 thus obtained is for single use and is thereforedisposable.

After filling, the orifice 30 of the cartridge (FIG. 5) is closed off bya protective cover 33 in order to guarantee satisfactory asepticconditions. It is also intended to interpose, between the dose ofproduct contained in the cavity of the cartridge and the protectivesealing cover, an elastomeric stopper 34 for enclosing the dose, thisstopper 34 being intended to communicate to the liquid the pressureexerted by the plunger of a striker.

According to an advantageous characteristic of the invention, theplunger of the striker is driven a few millimeters into the body of thecartridge so that the percussion force is directed and centered in theaxis of the elastomeric stopper 34, in order to prevent any risk ofbursting of the first glass element forming the cartridge 28.

According to another embodiment FIGS. 3-5 of the cartridge 28, thecartridge is empty and is filled by the user just before use.

The outer envelope of the said cartridge moreover has, on the one hand,means of fixing 35, 35' to the said body (screw pitch, spike, etc.) and,on the other hand, raised zones 36 allowing it to be gripped by theuser. The front face corresponding to the nozzle comprises, ifappropriate, a basin 37 whose depth is variable but guarantees that thejet issuing from the orifice of the nozzle has the time needed toestablish its hydrodynamics prior to the subcutaneous, intradermal orintramuscular injection.

The invention, as it has been described above, is very easy to use:there is no more sterilization, nor washing of the apparatus, while atthe same time increased safety for the user is guaranteed because of theabsence of a needle and the impossibility of reusing it without firsthaving reloaded the apparatus with a new dose, the method of fixing thecartridge avoiding all the risks of the latter bursting because of theabsence of a breech. This invention is advantageously adapted for use bya single user having no specific knowledge in the field of subcutaneous,intradermal or intramuscular injections, and it reduces, on the onehand, the risks of accidents, which are always possible with aninjection means having a needle, and, on the other hand, it eliminatesthe fear of stick injuries and any risk of contamination. The use ofthis device also allows the patient's chronobiology to be taken intoconsideration. This invention will have advantageous developments in theinjection of a dose of small volume, in particular of 0.05 to 0.2 ml. Itis of special interest for the administration of medicaments or vaccinesto man or animals. Among other products which may be mentioned arepolypeptides or peptides, such as enzymes and particularly calcitonin,used for the prevention of loss of bone substance and the treatment ofosteoporosis, or else medicaments against migraine. Other products, inparticular polypeptides or peptides, which may be administered using thedevice forming the subject of the invention, include hormones, such asinsulin, somatostatin, the growth hormone, clotting factors, for exampleantihaemophilic factors, plasma components, such as erythropoietin,antiviral polypeptides, such as interferons, or immunomodulators, suchas lymphokines. This device is also especially appropriate for theadministration of vaccine preparations.

Of course, the present invention is not limited to the illustrativeembodiments which have been described and represented above, but canencompass all variants thereof. Thus, the cartridges can be presentedbefore the rod of the striker with the aid of a barrel or a charger, andthey can also comprise the dose of the product to be injected.

What is claimed is:
 1. In a needle-free single use injection device of apharmaceutical product, the device having a cap relatively movablerelative to a device body for triggering a percussion member containedin the body, a cartridge mounted to a delivery end of the device, thecartridge containing the product and driven by the percussion member,and the cartridge comprising:a receptacle of preselected material andcontaining a single use quantity of the pharmaceutical product; a singleorifice formed in the receptacle for providing an exit for a jet ofinjected pharmaceutical product; an envelope made of a preselectedmaterial and molded over the receptacle; an end cap removably covering adelivery end of the cartridge that includes the single orifice; anelastomeric seal located in a central portion of the end cap for sealingthe orifice; and further wherein the end cap has lateral walls whichenclose the delivery end of the cartridge, the walls of the end capbeing provided with raised zones allowing them to be clipped intoimpressions provided on the outer lateral walls of the cartridge, thusensuring that the end cap is held on the cartridge.
 2. In a needle-freesingle use injection device of a pharmaceutical product, the devicehaving a cap relatively movable relative to a device body for triggeringa percussion member contained in the body, a cartridge mounted to adelivery end of the device, the cartridge containing the product anddriven by the percussion member, and the cartridge comprising:areceptacle of preselected material and containing a single use quantityof the pharmaceutical product; a single orifice formed in the receptaclefor providing an exit for a jet of injected pharmaceutical product; anenvelope made of a preselected material and molded over the receptacle;an end cap removably covering a delivery end of the cartridge thatincludes the single orifice; an elastomeric seal located in a centralportion of the end cap for sealing the orifice; and further wherein anouter wall of the end cap forms a grip zone which allows a user toposition studs of the cartridge in line with bayonets of the injectiondevice.
 3. In a needle-free single use injection device of apharmaceutical product, the device having a cap relatively movablerelative to a device body for triggering a percussion member containedin the body, a cartridge mounted to a delivery end of the deviceopposite the cap, the cartridge containing the product and driven by thepercussion member, and the cartridge comprising:a receptacle ofpreselected material and containing a single use quantity of thepharmaceutical product; a single orifice formed in the receptacle forproviding an exit for a jet of injected pharmaceutical product; anenvelope made of a preselected material and molded over the receptacle;an end cap removably covering a delivery end of the cartridge thatincludes the single orifice; an elastomeric seal located in a centralportion of the end cap for sealing the orifice; and further wherein theelastomeric seal is obtained during simultaneous moulding operation ofthe cap.
 4. In a needle-free single use injection device of apharmaceutical product, the device having a cap relatively movablerelative to a device body for triggering a percussion member containedin the body, a cartridge mounted to a delivery end of the deviceopposite the cap, the cartridge containing the product and driven by thepercussion member, and the cartridge comprising:a receptacle ofpreselected material and containing a single use quantity of thepharmaceutical product; a single orifice formed in the receptacle forproviding an exit for a jet of injected pharmaceutical product; anenvelope made of a preselected material and molded over the receptacle;an end cap removably covering a delivery end of the cartridge thatincludes the single orifice; an elastomeric seal located in a centralportion of the end cap for sealing the orifice; and further wherein theelastomeric seal is attached and fitted by force into a recess providedin an internal surface of the end cap.
 5. In a needle-free single useinjection device of a pharmaceutical product, the device having a caprelatively movable relative to a device body for triggering a percussionmember contained in the body, a cartridge mounted to a delivery end ofthe device opposite the cap, the cartridge containing the product anddriven by the percussion member, and the cartridge comprising:areceptacle of preselected material and containing a single use quantityof the pharmaceutical product; a single orifice formed in the receptaclefor providing an exit for a jet of injected pharmaceutical product; anenvelope made of a preselected material and molded over the receptacle;an end cap removably covering a delivery end of the cartridge thatincludes the single orifice; an elastomeric seal located in a centralportion of the end cap for sealing the orifice; and a plurality of gaps,formed in the thickness of the envelope molded over the cartridge, inorder to produce slots for improving the visibility of the receptacle.